MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X45MM; VIPER PRIME¿

Model Number 186770445

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-codes: kwp; kwq.Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the surgeon started inserting 7 x 45 mm screw into pedicle with 5 mm of stylet advanced.After tapping screwdriver over the stylet, the screw kept skiving off and the screw became loose, and not holding its trajectory.Upon closer investigation it looked like the cocr saddle had become loose.Both screwdriver and screw are available for collection.This is a consignment viper prime screwdriver and viper prime 7 x 45 mm screw.Both need replacing immediately to buderim private consignment kit.Expedium thoracic probes, straight were opened on consignment and loan trays, both were bent and needed to be replaced.All items have been tagged.Surgery was delayed 10 minutes due to the reported event.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection of the complaint device showed that the tulip head, bushing, and sleeve have separated from the screw shank, allowing it to spin freely with no resistance.In addition, the bottom tip is broken.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME CFXFEN XTAB 7X45MM
• Type of Device: VIPER PRIME¿
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9416713
• MDR Text Key: 169274836
• Report Number: 1526439-2019-52584
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: (01)10705034509617
• Combination Product (y/n): N
• PMA/PMN Number: K170543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Device Lot Number: NW153808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1